Mark Markowski, MD, PhD, discusses the results of a phase 1b/2 study examining treatment with sabizabulin in patients with metastatic castration-resistant prostate cancer.
Mark Markowski, MD, PhD, assistant professor of oncology, at Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins Medical Oncology, discusses the results of a phase 1b/2 study (NCT03752099) examining treatment with sabizabulin (VERU-111) in patients with metastatic castration-resistant prostate cancer (mCRPC).
Markowski noted that overall, sabizabulin was found to be safe and only mild toxicities were reported in phase 1 of the trial. Patients primarily had grade 1 or 2 adverse events, including fatigue and GI toxicities.
In the phase 2 portion of the study, some tumor reduction was seen, the overall response rate was in the 20% to 30% range, and the median progression-free survival was between 9-12 months.
0:08 | For the phase 1, dose finding study looking at safety, we did find that sabizabulin was pretty safe. It had mild toxicity, grade 1 or 2 primarily, and mostly fatigue and GI toxicities were diarrhea, nausea, and most patients did very well. We had a few grade 3 toxicities in the GI tract. Those were managed well with dose interruption or dose reduction. Again, from the safety perspective, patients did quite well in phase 1.
0:40 | Then we did see preliminary activity in phase 2. We saw some tumor reduction; we had an objective response rate in the 20% to 30% range. What we found is that patients were on the study for a long time. Progression-free survival was in the range of 9 to 12 months, but we had patients on study for 3 years and they continue on the study. There was some good disease control and in addition to some of the responses in terms of tumor reduction, we saw a lot of disease stability that was durable, so we were happy with it.